Wireless vaginal capsule and methods for monitoring fertility and pregnancy

ABSTRACT

The present invention may be embodied as a retrievable device capable of sensing one or more properties of an individual (e.g., chemical or physical parameters). In use, the retrievable device can continuously determine the chemical concentrations within the vaginal tract. An embodiment of the retrievable device comprises a first housing having a light source and an image capture device, a second housing removably connected to the lust housing and having a sensor, and a fitting for retrieving the device. The sensor may be an analyte sensor configured to obtain at least one measurement of a concentration of an analyte in a fluid. The analyte sensor comprises a sensor substance in a sol-gel material so the sensor substance reversibly interacts with an analyte of interest. In addition, the retrievable device can be configured to determine different physical parameters and re-implanted.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.13/808,463 entitled “A Device and Methods for in vivo Monitoring of anIndividual,” filed on May 17, 2013, which is a 35 U.S.C. 371 nationalstage entry of International Patent Application No. PCT/US2011/043759,filed on Jul. 12, 2011, which claims the benefit of priority to U.S.Provisional Patent Application Ser. No. 61/363,358 filed Jul. 12, 2010,the disclosures of which are all hereby incorporated herein by referencein their entirety.

FIELD OF THE INVENTION

The present invention relates to a device for biological monitoring, andmore specifically to a device for, and methods of, in vivo monitoring ofan individual.

BACKGROUND OF THE INVENTION

In recent years, ingestible devices containing sensors or cameras havebeen used by the medical profession as a way to monitor (e.g., measurethe properties of, etc.) the alimentary canal of individuals. However,previous devices have not been provided for retrievable implantation inan individual. Additionally, because of the nature of ingestibledevices, previous devices have been constructed as capsules that werenot reconfigurable and re-implantable.

Accordingly, there is a need fora retrievable device which will allowfor in vivo monitoring of an individual.

BRIEF SUMMARY OF THEINVENTION

A device according to an embodiment of the present invention isconfigured for retrievable implantation into an individual. The devicecomprises a first housing having a light source configured to illuminatea region of the environment external to the first housing—a“field-of-view.” An image capture device is disposed within the firsthousing, and positioned to capture an image of at least a portion of thefield-of-view. The device comprises a second housing configured to beremovably connected to the first housing and having a sensor. The devicealso has a fitting attached to the first housing, the second housing, orboth. The sensor may be electrically connected to the image capturedevice. The sensor ma also comprise a detector configured to detectelectromagnetic energy emitted by the sensor substance.

The sensor may be an analyte sensor capable of measuring theconcentration of an analyte in a bodily fluid present at theimplantation site. Such an analyte sensor may comprise a sensorsubstance in a sot-gel material. The sensor substance will emitelectromagnetic energy when in contact with the analyte of interest andelectromagnetic excitation energy is received by the sensor substance.Multiple sensor substances may he used. The multiple sensor substancesmay be the same sensor substance, different sensor substances, or acombination of similar and different substances. For example, an arraymay be formed from a plurality of sensor substances, each configured torespond to a different analyte of interest.

In another embodiment of a sensor according to the present invention,the sensor comprises a sensor substance in the form of an antibodybonded to a reporter molecule. The antibody is configured to interactwith an analyte of interest. The reporter molecule is configured torespond to interaction with an analyte by emitting electromagneticenergy (either independently or in the presence of excitation energy).

The sensor may be a parametric sensor for measuring a physical parameterof the environment external to the housing. For example, the physicalparameter may be sound, pH, temperature, pressure, or otherwise. Thedevice may further comprise a 3-axis accelerometer. In anotherembodiment, the sensor may be a 3-axis accelerometer.

The device may further comprise a transmitter, receiver, or both(separately or in the form of a transceiver) for communication withexternal devices.

The device may further comprise an electronic storage device, forexample, a memory device.

The invention may also be embodied as a method of monitoring anindividual. The monitoring may utilize a retrievable device for in vivomonitoring of the individual. The device may be similar to the devicedescribed herein. The method comprises the steps of implanting theretrievable device in the individual, using the retrievable device tomake at least one measurement of a first property of the individual, andusing the fitting of the retrievable device to extract the retrievabledevice from the implantation site of the individual.

The method may further comprise the step of configuring the retrievabledevice to make at least one measurement of a second property of theindividual. The retrievable device configured for a measurement of asecond property is re-implanted in the individual. And, the retrievabledevice is used to make at least one measurement of a second property ofthe individual.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature and objects of the invention,reference should be made to the following detailed description taken inconjunction with the accompanying drawings, in which:

FIG. 1 is a block diagram of the systems of a device according to anembodiment of the present invention;

FIG. 2 is a block diagram of the systems of a first housing according toan embodiment of the present invention;

FIG. 3 is a block diagram of the systems of a second housing, accordingto an embodiment of the present invention;

FIG. 4A is a cross-sectional view of a first housing according to anembodiment of the present invention, take along a longitudinal axis;

FIG. 4B is a cross-sectional view of a second housing according to anembodiment of the present invention, take along a longitudinal axis;

FIG. 5 is an exploded-view illustration of components of a deviceaccording to an embodiment of the present invention;

FIG. 6 is a cross-sectional view of a sensor according to an embodimentof the present invention;

FIG. 7A is a cross-sectional view of a second housing according to anembodiment of the present invention showing a piezoelectric pressuresensor configuration:

FIG. 7B is a side view of a piezoelectric sensor component;

FIG. 7C is a top view of the piezoelectric sensor component of FIG. 7B;

FIG. 8 is a top view of a system board assembly of a device according toan embodiment of the present invention;

FIG. 9 is a bottom view of the system board assembly of FIG. 8 ;

FIG. 10 is a cross-sectional view of a device according to an embodimentof the present invention, take along a longitudinal axis;

FIG. 11 is an illustration of an embodiment of a charge/calibrationstand and a device according an embodiment of the present invention;

FIG. 12 is a functional-end view of a power and data interface for adevice according to an embodiment of the present invention and a detailside view of a pin;

FIG. 13 is a flowchart describing a method according to an embodiment ofthe present invention:

FIG. 14 depicts a device according to an embodiment of the presentinvention; and

FIG. 15 depicts a device according to an embodiment of the presentinvention having sensor modules.

DETAILED DESCRIPTION OF THE INVENTION

A device 200 according to an embodiment of the present invention,depicted in FIG. 14 , is configured for retrievable implantation into anindividual. It should be noted that the terms “implanted” or “inserted”are used interchangeably throughout this disclosure and should hebroadly interpreted as placing the device into an individual.Implantation into an individual allows the device 200 to perform “invivo” monitoring (e.g., measure a parameter, etc.) of an individual, Inan embodiment, the device 200 may be configured to be implanted into abody orifice of the individual. For example, where the individual is amammal, the device 200 may he configured to be implanted in the mouth,the anus, the vagina, etc. The device 200 may be sized, shaped, and/orotherwise configured differently depending on the intended implantationsite. For example, a device 200 according to an embodiment of thepresent invention may be capsule shaped.

The device comprises a first housing 202 having a light source 206. Thelight source 13 is configured to illuminate a region of the environmentexternal to the first housing 202—a “field-of-view.” The light source206 May be a light-emitting diode (“LED”). The light source 206 may belocated within the first housing 202 such that the first housing 202protects the light source 206 from fouling by any bodily fluids that maybe present m the implantation site. In such embodiments, the firsthousing 202, or at least a portion of the first housing 202. may betransmissive so that the light from the light source 206 can passthrough the first housing 202. The light source 206 may he configured toilluminate a field-of-view at the leading end of the device 200 (whenthe device 200 is configured to have ends—e.g., a capsule shape).Alternatively, the light source 206 may he configured to illuminate afield-of-view at a trailing end of the device 200, or a field-a-view ata side of the device 200. The field-of-view may be wide or narrow assuited to the purpose of the device 200. The illumination may be of anybrightness and color temperature as suited to the purpose of the device200.

The device 200 also includes an image capture device 208 disposed withinthe first housing 202. The image capture device 208 may be, for example,a still camera, a video camera, or a camera capable of both still imagecapture and video capture. The image device 208 may be, for example,capable of capturing three-dimensional image information. For example,the image capture device 208 may comprise multiple image sensors spacedapart from each other at a fixed distance. In this way, each imagesensor will capture a view of the scene from a different perspective,and the perspective images can be merged to provide three-dimensionalimage data The image capture device 208 may be, for example, an infraredcamera and/or a visible light camera The image capture device 208 ispositioned to capture an image (or multiple images) of at least aportion of the field-of-view. At least a portion of the first housing202 is transmissive in order to allow light to pass through to the imagecapture device 208. For example, at least a portion of the first housing202 may be clear (i.e., transparent). In an embodiment, a portion of thefirst housing 202 may be shaped in order to act as a lens for the imagecapture device 208. The lens may be configured to show a magnified view,a wide-angle view, or otherwise. In certain cases, the lens may distortthe optical view of the image capture device, for example, the lens maybe a so-called “fish-eye” lens capable of a wide field-of-view, butdistorting the image. A portion of the first housing may be configuredto act as a filter in order to filter certain wavelengths of light fromreaching the image capture device 208.

The device 200 further comprises a second housing 204 configured to beremovably connected to the first housing 202. For example, the secondhousing 204 and first housing 202 may screw to one another, clip to oneanother, or otherwise attach in a removable fashion. Such removableconnection allows a device 200 according to the present invention to beflexibly configured with additional modules (further detailed below)and/or reconfigured to include different first or second housings withdifferent components within.

The second housing: 204 of the device 200 further comprises a sensor210. The sensor 210 may be configured for monitoring (e.g., measuring,etc.) a parameter of the individual. Various embodiments of the sensor210 are further described below.

The device 200 further comprises a fitting 212 attached to the firsthousing 202, the second housing 204, or both. The fitting 212 is used toretrieve the device 200 from the implantation site. The fitting 212 canbe an orifice for snagging, the device 200 with a hook or similar tool,a threaded orifice for securing a threaded tool, a string, a rod, or anyappendage for grasping the device 200, site for use of a tool forretrieving the device 200, or other configuration to aid in theretrieval of the device 200.

In an embodiment of a device 200 according to the present invention, thesensor 210 is electrically connected to the image capture device 208. Inthis manner, the sensor is able to generate a signal for controlling theoperation of the image capture device 208.

The sensor of a device according to the present invention may be ananalyte sensor capable of measuring the concentration of an analyte in abodily fluid present at the implantation site. For example, the analytesensor may be capable of measuring relatively small molecules (e.g.,glucose) or relatively large molecules (e,g., proteins—hemoglobin). Thecapabilities, function, and structure of such analyte sensors isdescribed in further detail infra An embodiment of an analyte sensor isconfigured to obtain at least one of measurement of the concentration ofan analyte in the bodily fluid. The analyte sensor may be configured toobtain a plurality of measurements. The analyte sensor may be configuredto make continuous measurements. In an embodiment 44 of an analytesensor depicted in FIG. 6 , the analyte sensor 37 comprises a sensorsubstance 50 in a sol-gel material. Sol-gel materials include materialsderived from a sol-gel process. The sensor substance 50 is configured toreversibly interact with analyte of interest. The sensor substance 50may be able to sample an analyte at a rate of approximately one secondor less, depending on the analyte and configuration of the analytesensor 37. The sampling rate may be higher for larger molecules, orlower for smaller molecules. In addition, the analyte sensor itself maybe disposed within the housing or external to the housing.

When the sensor substance 50 is in contact with the analyte of interestand electromagnetic excitation energy is received by the sensorsubstance 50, the sensor substance will emit electromagnetic energy. Forexample, the sensor substance 50 may be exposed to electromagneticexcitation energy in the form of light energy. Such a sensor substance50 is also configured to react to a specific analyte of interest (e.g.,glucose, etc.). When such a sensor substance 50 is exposed to theanalyte of interest and the excitation energy, the sensor substance 50will emit energy, for example the sensor substance 50 may fluoresce.Other forms of electromagnetic excitation energy (e.g., infrared,ultraviolet, etc.) can by used. The sensor substance 50 can beconfigured to emit energy in different ways and in different forms. Forexample, the sensor substance 50 can be configured to emit modulatedlight energy, or energy of specific wavelengths, or otherwise.

Multiple sensor substances may be used For example, an array may beformed from a plurality of sensor substances, each configured to respondto a different analyte of interest. In this way, multiple chemicalparameters (i.e., concentrations of multiple analytes) may be measuredsimultaneously.

The sensor substance 50 of a device 200 according to an embodiment ofthe present invention is configured to be in contact with the bodilyfluid. In an embodiment, the sensor substance 50 may be located withinthe external bounds of the second housing 204. In such an embodimentportions of the second housing 204 may include one or more apertures 52through which bodily fluid may move to contact the sensor substance 50.A cover material, such as, but not limited to, a membrane 45 or a mesh,may cover the apertures 52 and allow the bodily fluid to pass through.In another embodiment, the sensor substance 50 is located on the secondhousing such that the sensor substance 50 is exposed to the bodily fluidwithout the solid particles of the respective fluid passing into thedevice 200.

In an embodiment of the present invention, the analyte sensor 44 isconfigured to generate a signal for controlling the device 200. Forexample, the analyte sensor 44 may be configured to generate a signal tothe image capture device 208, such that the image capture device 208will capture an image. In another example, the analyte sensor 44 may beconfigured to detect hemoglobin and trigger the image capture device 208to capture a plurality of images. Such an embodiment is useful fordetecting and photographing portions of the individual which may bebleeding. Other sensor configurations are possible and within the scopeof the present invention.

The analyte sensor 44 of embodiments of a device 200 of the presentinvention may also be configured to continuously measure a concentrationof analyte in the bodily fluid. In an embodiment, the analyte sensor 44is configured to be reversible. The term “reversible” or “reversibility”as used herein refers to the ability of the analyte sensor 44 to detectthe presence of an analyte within a sample in a continuous manner as thesample concentration within the sample increases and decreases and to doso in an unbiased manner. The presence of the analyte is identified hrdetecting a signal that is indicative of the analyte concentration. Theabsence of the analyte can be identified by a lack of a detectablesignal or a signal that is not significantly different than thebackground signal. Upon re-exposure to the analyte the signal can againbe recorded. Any change over time in the concentration of the analyte inthe immediate environment of the sensor results in a signal .from thesensor that is readily correlated to the analyte concentration in thesample at the point in time of the signal measurement. The signal isalso an accurate and precise measure of the analyte concentration atthat specific point in time. The reversible nature of the interactionbetween the sensor and the analyte allows detection of an analyte in acontinuous manner and no change in temperature or pressure or othermeans (e.g., pH swing, chaotrope, denaturant, etc.) is required todisengage/dissociate the analyte from the sensor. We have successfullyused the present method for reversibly and continuously detectinganalytes over a period of several months. For example, the signal fromthe chemical sensor was continuously detected over a period of at least30 days with minimal drift (relative standard deviation≤5%). Thereversible nature of the analyte sensor 44 can be performed throughphysical or chemical means. For example, an optical fiber brush may beemployed to clear the active surface of the anal to sensor betweenmeasurements. In another example, the analyte sensor 44 can beconfigured to detect the analyte as it flows through the sensor.

In another embodiment of a sensor according to the present invention,the sensor comprises a sensor substance in the form of an antibodybonded to an optically active (e.g., fluorescent) reporter molecule. Theantibody is configured to interact with art analyte of interest, Thereporter molecule is configured to respond to interaction with ananalyte by emitting electromagnetic energy (either independently or inthe presence of excitation energy). The analyte may be captured by thesensor for analysis (e.g., ELISA assay, etc.).

The sensor may also comprise a detector 17 configured to detectelectromagnetic energy emitted by the sensor substance 50 (see, e.g.,FIG. 4B). For example, in sensors haying fluorescent or otherwiseluminescent reporting capabilities (e.g., the aforementioned sol-gelbased and antibody-based methods, or others), a detector 17 may be usedto sense the energy emitted by such activity, In an embodiment, thedetector 17 is a CMOS detector that monitors the emitted energy. Inanother embodiment, the detector 17 is an array of CMOS detectors.Configuring CMOS detectors to react to certain wavelengths of light iswell-known in the art. In an embodiment, the detector 17 is aphotodiode. The device 200 may also comprise a controller 34 inelectronic communication with the detector 17 for measuring aconcentration of analyte based on the detected electromagnetic energy.The controller 34 may compare the detected electromagnetic energy with aknown value, or may calculate analyte concentration based on analgorithm specific to the known electromagnetic response.

The sensor substance 50 may require electromagnetic excitation energy inorder to respond when in the presence of an analyte. In an embodiment,electromagnetic excitation energy is provided to the sensor substance 50by the light source 13 of the first housing. If additional light sourcesare employed, these light sources may also provide the requiredelectromagnetic excitation energy. The sensor substance 50 may receivethe energy through ambient radiation, or the energy may be directed as,for example, a light channel through a fiber-optic cable, in anotherembodiment, the analyte sensor 37 further comprises an electromagneticexcitation energy source 13 configured to provide electromagneticexcitation energy to the sensor substance 50. For example, the energysource 13 may be a driving LED configured to emit a specific wavelength,or wavelength range of light. The driving LED may also produce amodulated signal to aid in the computation of analyte concentration.

The sensor 210 may be a parametric sensor for measuring a physicalparameter of the environment external to the housing. For example, thephysical parameter may be sound, pH, temperature, pressure, movement(3-axis accelerometer), or otherwise. The parametric sensor may includediodes, capacitive pressure sensors, and microphones. Other parametricsensors as known in the prior art could be adapted for use in thedevice. The parametric sensor may comprise a piezoelectric materialconfigured to measure pressure.

A device according to an embodiment of the present invention, depictedin FIGS. 4A and 48 , may further comprise a first housing sensor 38disposed in the first housing 1. The first housing sensor 38 may be ofany type, such as those described above.

A device 300 according to an embodiment of the present invention,depicted in FIG. 15 may comprise one or more sensor modules 316. Eachsensor module 316 is configured to be removably connected between thefirst housing 302 and the second housing 304. Each sensor module 316 hasat least: one sensor 318 disposed within. In this way, a device 300according to embodiments of the present invention may be configured withone or more sensor modules 316 with the same or different sensors 318selected according to the needs of the individual. The device 300 mayalso be retrieved, reconfigured, and re-implanted as the needs of theindividual change or are better understood. For example, a device may beimplanted to detect: temperature (via the sensor) and monitor throughpictures. If the temperature rises above a determined threshold, thedevice can be retrieved and reconfigured to have a sensor module capableof detecting an infection. For example, a sensor of the sensor modulemay have an analyte sensor. The reconfigured device may then bereimplanted in the individual.

In an embodiment, the device may further comprise a 3-axis accelerometer32. In another embodiment, the sensor may be a 3-axis accelerometer 32.By, way of examples, this would record patient activity such as crampingduring pregnancy which might indicate premature delivery or daily energymonitoring for assistance with the treatment of diabetes,

The device 101 may further comprise a transmitter, receiver, or both(separately or in the form of a transceiver). The transmitter and/orreceiver may be in electronic communication with the image capturedevice, the sensor, or both. In an embodiment, a transceiver is usedconfigured to transmit collected data to an external device. Forexample, the transceiver may transmit data from the sensor, the imagecapture device, or both to a console monitored by an operator. Thetransceiver may also accept commands for control of the device'ssystems. It should be noted that the terms “transceiver” and“transmitter and/or receiver” are used interchangeably throughout thisdisclosure, and should be given the broadest interpretation as at leastany device configured to transmit and/or receive information. In anexample, the transceiver may send data to an operator's console, wherean operator may detect a condition where an image should be captured bythe image capture device. Other functions will follow from the inclusionof a transceiver in a device.

The device 200 may further comprise an electronic storage device 214,for example, a memory device. The electronic storage device 214 maystore data from the sensor 210 and/or the image capture device 2031 orlater retrieval of such data.

The invention may also be embodied as a method 100 of monitoring anindividual. The monitoring may utilize a device as previously describedfor retrievable implantation for in vivo monitoring of the individual.The method 100 comprises providing 103 a retrievable device. The devicemay be of any embodiment described herein where the device comprises afirst housing having a light source for illuminating a field-of-view.The first housing of the device also has an image capture devicepositioned to capture an image of at least a portion of thefield-of-view. The device further comprises a second housing with asensor. The second housing is configured to be removably connected tothe first housing. The device further comprises a fitting for retrievingthe device.

The method 100 comprises the step of implanting 106 the retrievabledevice in the individual. As stated above, implantation (insertion) maybe implantation in a body orifice, for example (in a mammal) the mouth,the rectum, the vagina, or otherwise. The retrievable deice is used 109to make at least one measurement of a first property of the individual.For example, the sensor of the device may he an analyte sensor, and theanalyte sensor may be used to measure the concentration of an analyte ina bodily fluid of the individual. In another example, the sensor may bea parametric sensor for measuring a physical parameter, such as withoutlimitation, temperature, pressure, sound, or pH. The sensor may makecontinuous measurement of the property of the individual. The fitting ofthe retrievable device is used 112 to extract the retrievable devicefrom the implantation site of the individual.

The method 100 may comprise the step of using 115 the image capturedevice to capture at least one image of a portion of the individual. Theportion of the individual is proximate to the retrievable device. Forexample, in the case where the retrievable device is inserted into thevagina of an individual, the image capture device may be used to captureimages (including still, video, 3D, etc.) of the cervix of theindividual. The sensor and the image capture device may be electricallyconnected, and the method 100 may comprise the step of controlling 118the operation of the image capture device with a trigger signalgenerated based on the at least one measurement. For example, in theabove example where the retrievable device is inserted in the vagina ofan individual, the sensor may he able to measure movement or pressure(for example, caused by a contraction during labor) and generate asignal to the image capture. device to capture an image of the cervix.In this way, a medical professional may monitor the dilation of thecervix of an individual during labor.

The retrievable device may have a transmitter and/or a receiver. Thetransmitter may be configured to transmit 121 signals received from thesensor and/or image capture device. For example, the value of ameasurement made by the sensor may be transmitted to an external devicefor monitoring by an operator. Similarly, in another example, imagescaptured by the image capture device may he transmitted by thetransmitter to an external device. The receiver may he configured toreceive signals from an external device (e.g., a remote transmitter). Inthis way, an operator using an external device may trigger the imagecapture device to capture an image and/or the sensor to take at leastone measurement.

The method 100 may further comprise the step of configuring 124 theretrievable device to make at least one measurement of a second propertyof the individual. For example, the second housing (and sensor) may bedisconnected from the first housing and the second housing may beexchanged for an alternate second housing With a different sensor (andreconnected to the first housing). In another example, the secondhousing may be disconnected from the first and the sensor within thesecond housing exchanged for an alternate sensor. In another example,one or more sensor modules each having at least one sensor may beconnected between the first housing and the second housing. In this waythe retrievable device may be reconfigured in any of various ways totake a measurement of a second property (or several properties).

The retrievable device configured for a measurement of a second propertyis re-implanted 127 in the individual. And, the retrievable device isused 130 to make at least one measurement of a second property of theindividual.

Additional exemplary embodiments of the above-described device andmethod are provided below.

A capsule for vaginal use may be small enough to be easily inserted,functional over days of continuous use, and biologically inert. Thetransmission signal is strong enough to be received by a remotereceiver, and the receiver may be small enough to be carried by theindividual. In an embodiment a remote receiver is a mobile phone orhandheld computer device with storage and communication features. Eachcapsule max transit or receive data using one of 256 available digitaltransmission channels to reduce interference from other transmissionsources (or other capsules) in the near vicinity. The capsuletransmitter operating in conjunction with the capsule receiver and anexternal capsule receiver may incorporate an adaptive. transmitter powerlevel control algorithm. Transmitted power may automatically be adjustedto create the lowest data error rate. This approach reduces the powerconsumption of the capsule by limiting the transmitted power level tothe lowest value required to produce a low error rate transmission.

The present invention broadly provides for a practical vaginallyinserted capsule that is arranged to sense one or more chemical and/orphysiological parameters within a individual, and to transmit suchparameters to an extra-corporeal receiver, In use, the capsule andreceiver perform the method of continuously determining the chemicalconcentrations and physiological measurements within a vaginal tract ofa mammal. These measurements allow remote visual monitoring of thecervical opening during pregnancy. During the time that vaginal anatomyis under video monitoring, there is additional advantage gained by thecontinuous sensing of chemicals and proteins (see U.S. Pat. Nos.6,241,948 and 6,589,438) in the fluids of the vaginal canal of a mammal.This highlighted section is the good stuff on the combination of thetechnologies. Previous embodiments of capsules have not been able toprovide data regarding physical activity at the patient or quantify themagnitude, duration and frequency of contractions occurring in latepregnancy. By incorporating two piezoelectric foil based compressiveforce. (pressure) sensors covering 60% of the capsules outer shellcircumference and the incorporation. of a three-axis accelerometerwithin the capsule, data can be collected regarding patient physicalactivity and contractions. The capsule can monitor the heartbeat of themother and fetus. The capsule also contains a high resolution, fastresponse temperature sensor used to monitor patient vaginal temperatureand assist with calibration of chemical and physical sensors to ensurehigh accuracy measurements. Vaginal temperature is helpful in monitoringinfection or the hormonal cycles of the mammal to assess fertility.

An embodiment of a method includes the steps of inserting and wearingthe vaginal capsule, the vaginal capsule having one or more sensors forchemical and physical characteristics; transmitting a signal from thecapsule; receiving the transmitted signal; determining the real-timeconcentrations of substances in the fluid of the vagina of a mammal; anddetermining the real-time physical properties of the vaginal canal andcervical opening as a function of the received signal(s). The receiveddigital photograph signal also indicates the visual status at the timeof chemical and physical measurements of one or more sensed parameters.The capsule may contain a receiver that provides for external orinternal (pre-programmed) sample-on-demand functions that may beinitiated by sensed parameter pre-set thresholds or initiated by aclinician examining the transmitted data from the capsule in real time.Additionally, data captured by the capsule may transmitted to a PersonalComputer (PC) or to a patient worn device such as a wristwatchcontaining a transceiver and display or a smart phone with a Bluetooth™application for Monitoring the capsule.

The capsule can be powered by small primary or secondary (rechargeable)type batteries. The invention incorporates an activation system foreither type of battery chemistry, calibration and recharging system thatprovides a device that can be used for a month or longer in the sameindividual. The materials used for the vaginal pills outer shell will bechosen to allow the use of FDA approved cleaning solvents between useswithin the same patient.

An embodiment for this device would not include the chemical sensingsystem. and its associated detector. This embodiment would yield adevice capable of measuring patient activity, heartbeats from mother andfetus, vaginal contractions and visual observations of dilation of thecervix. For this embodiment the sample-on-demand functions that may beinitiated by the start of a contraction as sensed by the accelerometer,heart rate, temperature and pressure sensors.

An embodiment for this device would not include the chemical sensingsystem and its associated detector. This embodiment would include thecamera, the accelerometer, and the acoustic and piezo pressure detector.This embodiment would yield a device capable of measuring patientactivity, heart rate of mother and fetus, frequency and duration ofcontractions, and provide photographic images of dilation of the cervix.For this embodiment the sample-on-demand functions that may be initiatedby the start of a contraction as sensed by the accelerometer andtemperature sensors.

In an embodiment, a chemistry sensor device is included with a batteryand transmitter-receiver and used to monitor glucose concentrations invaginal fluid in a diabetic patient in need thereof.

FIGS. 1, 2, and 3 illustrate the main electronic components and theirelectrical interconnections as a generalized functional block diagramfor several embodiments of the present invention. Discrete componentssupporting each of the major function blocks are not illustrated inthese figures. FIG. 1 illustrates components used to produce a singledevice which embodies the present invention. FIG. 2 illustrates anembodiment of the invention using components suited for a low costdisposable device that also supports remote healthcare providerexamination and monitoring of vaginal and cervical status in a pregnantwoman. FIG. 3 illustrates the components in an embodiment with a modularchemical sensing system thereby expanding the functionality of theembodiment illustrated in FIG. 2 .

The electronic components used within the present invention may includean image capture device 14. For example, the image capture device .14may be a small (2 mm×2 mm) CMOS, video-capable, color camera The cameramay have excellent low light sensitivity. The camera may be mounted atthe front (first inserted) end of the device. Camera activity may beevent driven to reduce power consumption and to ensure that largoamounts of image data does not have to be reviewed to find an area ofinterest. The image can be displayed on a cell phone screen ormonitoring device, allowing adjustment of capsule positioning by thepatient or by a medical person working with the patient. The image maybe transmitted from the cell phone for further processing. A clinicianmonitoring the data outputs can activate the camera hi addition, thecapsule's internal program may activate a camera if a sensed dataparameter exceeds a preprogrammed threshold. The CMOS camera is capableof operation in both still frame and continuous video modes.

An example of still frame (single image) operation may include when theaccelerometer shows a close frequency of contractions and motions whichmay be indicative of a patient going into labor. This event or series ofevents can activate the camera functions of the device in order todetermine the status of the cervical opening. A continuous video modemay prove useful to observe contraction activity, monitor the size ofthe cervical opening, check for abnormal discharges from the cervix, ordirectly observe conditions such as bleeding or discharge due toinfection, In an embodiment., the images and the accelerometer mayindependently track data, for example monitoring physical activity onthe accelerometer side, while monitoring cervical or vaginal canalfunctionality on the image side. This embodiment is designed to be wornfor short periods of time and capture real-time images. In most, but notall embodiments, the device is inserted so that the camera is forward. Arecovery fitting can be placed on the opposite end of the device by useof a removable end cap.

It should also be noted that the removable end cap 63 may be anattachment point for the disposable laboratory module component of thevaginal capsule. This module can perform laboratory analyses for manyconditions. One configuration of the laboratory module is to defineconditions under which the camera module would be activated to captureimages. One example includes the detection of an infection, bleeding, orcancers by means of biomarkers, and then issuing a command to image thecervical opening in cases where the source of bleeding, infection, orcancer can be determined by visual inspection of the video signal orstill frame photograph. The images and video from image capture device14 may be passed to a buffer memory (not illustrated) for storage untila data transfer is requested by an external monitoring device.

The laboratory module can function independently of the camera moduleand would ordinarily function separately if the goal were to monitorchemical conditions such as glucose in a diabetes patient, or in anotherembodiment, vaginal fluid biomarkers beneficial in the detection offertility or in a hormone replacement program, or monitoring of chemicalconditions such as biomarkers of organ function, metabolic functions ordisease detection or diagnosis. Each of the biomarkers could be measureda single time, or continuously over the battery life of the capsulemodule.

While each module can function independently from the other to performits functions, an embodiment would involve a connected first housing 1and second housing 2. The combined components would include the shortduration features of a disposable laboratory module, and these functionsinteract in a data driven directive to the imaging module to takepictures or movies in defined conditions, such as impending delivery oronset of infection.

In an embodiment, one or more light sources 13, for example, LightEmitting Diodes (LEDs), can be arranged in a directional manner toprovide adequate illumination. The LEDs may be any color includingwhite. The LEDs can operate in a high-power, pulsed flash mode forsingle frame camera operation, or a burst illumination mode for videorecording. The microprocessor 34, the light circuit 12, and the powerswitch 33 may control the operational mode and synchronization of theLEDs to the camera. The light circuit 12 may provide either ahigh-power, short duration pulse to flash the light sources 13 in thecamera still frame mode, or continuous lower power short duration pulsessynchronized to the camera's frame rate for camera operation incontinuous video mode. The camera LED synchronization, mode, imagestorage and trigger can be controlled by the microprocessor 34.

In the laboratory module, chemical sensing of analytes contained withinthe fluid may accomplished in an embodiment by a system comprising a LEDdriver 31, Sensor LEDs 16, sensor cell 37, and sensing array 17—allcontrolled by a microprocessor 34. Microprocessor 34 can initiate takinga sample at a preprogrammed sampling rate or by an external trigger. Thesampling rate can also be modified due to a previous sensed parameterthreshold-crossing event. The LED driver 31 can he activated at eachsampling interval thereby illuminating a plurality of sensors LEDs 16,which provide optical radiation to and are, focused on the input side ofthe sensor cell 37. For example, there may be between 4 to 6 sensor LEDs16. In an embodiment, sensor cell 37 is filled with normal saline (0.91%w/v of NaCl) combined with suitable osmotically active, large moleculesas to affect no net loss of fluid inside the capsule when it is inside amammal. The capsule may also contain an active xerogel-based,analyte-responsive site or sites. Each xerogel site can be formulated torespond by a change in its spectroscopic signature (e.g., electronicabsorbance, polarization photoemission of fluorescence, phosphorescenceor chemical luminescence, and/or Raman spectroscopy) to a specificanalyte. The sensor cell 37 may have multiple chemical sensing sitescontained within the cell. Fluid communication between the xerogelsensor sites and the environmental fluids may be accomplished bywrapping the outer circumference of the cell with a semi-permeablemembrane. Fluids and dissolved chemical substances are allowed toequilibrate between the fluid in the capsule and the fluid in theenvironment. After equilibration across the semi-permeable membrane, theconcentration at the sensor site will be the same as the concentrationin the environmental fluid. A spectroscopic filter can be located belowthe xerogel sensing composites to reduce the transmission ofelectromagnetic radiation not in the frequency band of the desiredspectroscopic signal (absorbance, emission, polarization, scattering)from the xerogel sensing sites. The sensing array 17, for example a highresolution Complementary Metal Oxide Semiconductor (CMOS) detectorarray, can monitor the optical radiation from the plurality of xerogelsites and detect an active site. The level of activation may be passedto microprocessor 34 as an analog value, which can be digitized, stored,reported as a concentration with respect to time and may be furtherprocessed to determine if event initiation is warranted.

In an embodiment, the first housing 1 contains a 3-axis accelerometer 32to measure the magnitude, frequency, acceleration and direction ofpatient movement. Data from this device can provide detailed informationon patient daily physical activity. Accelerometer data may also be usedin conjunction with the data from the capsule pressure sensors in firsthousing 1 to analyze and monitor contractions in the later months ofpregnancy. Accelerometer data may also be used in conjunction with thedata from the capsule pressure sensors to analyze and monitorcontractions. Here, contractions are notable as “cramps” in the latermenstrual cycle and analysis of these signals can be used to monitor theeffects of medications given to ease the pain and discomfort.Digitization, processing of digitized data, data storage, andmeasurement interval for the accelerometer may be controlled by amicroprocessor 34. In an embodiment of the present invention, thelaboratory module may be changed periodically and as needed to providecontinuous monitoring of chemical and biomarker data from the patient.

To monitor contractions as an indication of impending birth in the latermonths of pregnancy, an embodiment of the present invention as shown inFIG. 2 incorporates two piezoelectric polymer pressure sensors 7, twoJunction Field effect (JFET) operational amplifiers 29, that providefiltering and noise reduction of the sensors output voltage, a highresolution voltage reference 53 to drive the amplifiers, a power switch33, a thermistor 38, and scaling circuit 30 to measure patienttemperature in order to compensate in calculating the values read by thepressure and other sensors. Both the piezoelectric sensors andthermistor can be located within the capsule near the outer surface. Thecapsule shell may be composed of a semi-rigid plastic or low durometer,FDA approved encapsulant. These, and other materials, can transmit theforce of contractions to the pressure sensors. Positioning thethermistor near the outer shell surface of the pill reduces the thermallag time between the environmental tissue and the sensor, therebyenabling faster sensor response to temperature changes of the tissue.

Microprocessor 34 may control the function of the first housing 1 andsecond housing 2 including data storage, data transmission, commandreception, both internal camera control and remote camera control, CMOSsensor array operation, accelerometer operation, pressure sensorsampling and temperature measurement, and sensor compensation andcalibration. Battery power conservation may also be controlled by themicroprocessor 34 by offering a variety of low power operation modesthat can he used between active measurement and transmission periods.Power to each function module can be controlled by the microprocessor 34through power switch 33 by turning off each system once it has completedits task. In this manner the average power consumption of the capsule isminimized. The integrated circuit containing the microprocessor may alsocontain a full duplex software radio transceiver that is 802.11acompliant and capable of transmitting collected data and video once themicroprocessor data memory is full. The microprocessor may also acceptexternal commands for control of the capsule's sub systems from anexternal monitoring device such as a cell phone. In an embodiment, anantenna 36 is provided. It may comprise a fractional wavelength ceramicchip type antenna. Antenna performance and design can be modeled as anassembly including the proximity battery outer shell to optimize RFperformance. The radio can be implemented using a series of programmableregisters which allows software tuning of performance and offers 256transmission/reception digital channels.

In an embodiment of the invention, the battery 39 is comprised of tworechargeable coin cells connected placed in parallel. For example., thebattery chemistry can have Lithium-Ion secondary chemistry with anominal full charged voltage of 3.4 to 3.7 Volts. Battery terminals 22and 23 may be integrated to the capsule's outer shell and can befabricated using non-corrosive metals such as gold. Charging terminalscan he located on the side of the capsule assembly. In an embodiment, toactivate the capsule, the battery is charged prior to use by piercingthe capsule's compliant outer shell with pointed charging terminalsaligned with the battery terminal locations of the capsule. In thisembodiment, the capsule battery terminals are covered by a self-healingsilicone rubber compound that maintains the capsules outside seal, whenthe charging terminals are removed once charging is completed.

The second housing 2 laboratory can also be powered by a disposablebattery 39 which is comprised of one or more non-rechargeable coin cellsor rechargeable battery chemistry cells may be used as illustrated inFIG. 3 .

FIGS. 4, 5 and 12 illustrate additional detail unique to the modularapproach for this invention. FIG. 4 illustrates an embodiment of boththe stand alone sensing module in the first housing 1 and the chemicalsensing module in the second housing 2. Standalone operation end cap 63with molded grip 64 is fitted to the capsule as shown. This cap may bescrewed on to the capsule or a molded snap arrangement may be used tosecure the cap. The cap can easily be. removed (for battery replacementor charging) using molded grip feature 64. Sealing of the capsule may beaccomplished using a thin “O” ring 62 A power switch is incorporatedinto both the cap and the power and interface board 65. For standaloneoperation of the first housing 1 the power switch can be formed usingthe center and first etched conductive concentric rings of the interfaceboard 65. Pins on the cap Detail A can short these two connection pointsactivating the module. In an embodiment, this approach provides 4connection points for each ring eliminating alignment issues.

The interface board set 65 & 69 in FIG. 12 may contain as manyconcentric rings and pins necessary to provide a data interface betweenthe chemical sensing unit module 66 of the second housing 2 and firsthousing 1. The second housing 2 may contain its own microprocessor toprocess and format the sensed data. This information is then transferredto the first housing 1 for wireless transmission to a receiving device.Both of these modules as well as the composite capsule can be fabricatedusing a rigid flex PCB configuration. See FIGS. 8 and 9 . The locationand number of components will differ for each embodiment.

FIG. 5 illustrates one assembly sequence for the first housing 1. Thisassembly method can simplify the assembly, thereby reducing cost andassembly errors. It also supports subassembly in-process testing toincrease reliability and reduce production fallout for the device.

FIG. 6 is a detailed drawing of the chemical sensing cell 37 which canbe used in either the first housing 1, the second housing 2, or thecombination of the housings. The sensing cell 37 can be pre-fabricatedand calibrated at the factors. In the example of a modular sensingsystem, such as in FIG. 3 , the sensing cell module can be screwed orsnapped onto first housing 1 by the patient and that action may alsoactivates the power switch for both housings to perform laboratoryanalyses and data reporting. The sensing cell 37 can be comprised of aninjection molded circular outer shell 43 with two internal lips 42 and47. In an embodiment, the front lip 42 has a larger opening diameterwhile the rear lip 47 has a smaller opening diameter. For example, thefront lip opening may be 12 mm while the rear lip opening may be 9.6 mm.These features are designed to provide attachment and sealing points foroptically clear windows 41 and 49. The larger front lip opening 42provides a simple method for assembly of the cell windows from the frontof the device through the opening created by lip 42 using a smallerdiameter window 49 for the rear of the cell. For example, the diameterof the front window 41 can be 15 mm while the diameter of the rearwindow 49 can be 11 mm. In another example, both windows are 1.5 mmthick clear optical cast plastic windows offering broad band lighttransmission of >90%. The front and rear windows 41 and 49 form a liquidtight seal between the sensing cell and the substrates 9 in FIG. 4 ofthe rigid flex assembly. The length of the outer shell 56 may be suchthat a lip extends beyond windows 41 and 49 to form an alignment featurefor the rigid flex assembly substrates containing the sensor LEDs 16 andthe sensor array 17. This feature is illustrated as callouts 51 and 48.The rear window of the cell can face the sensor array 17 and may have anoptical filter 46 deposited or attached to it. The sensor substance 50can also be printed to the inside surface of this window. The sensingcell outer shell 43 may also has elongated slots 52 molded into thecircumference of the shell providing a fluid path. The cell can befilled with 0.9% w/v of NaCl, normal saline and a quantity of highmolecular weight dextran or suitable alternative to maintain osmoticpressure. The elongated slots 52 can be covered with a semi-permeablemembrane 45 that allows fluid flow/exchange to and from the cell.

The first housing 1 or second housing 2 may incorporate a PiezoelectricPolymer Pressure sensing system to measure the amplitude, duration andfrequency of contractions occurring in the later months of pregnancy.Details of this sensing system are illustrated in FIG. 7 . These sensorscan also provide acoustic sensing of patient respiration and heart ratemeasures from both mother and fetus. Alternatively, a small microphone68 may also be incorporated to provide this function.

In an embodiment, two semi-flexible sensors 7 are located approximately2 mm from the outer surface 8 of the device and cover approximately 60%of the pills circumference as indicated in the side view in FIG. 7 . Theouter case of the device can be distortion compliant-meaning it willdeform with each contraction. This can be accomplished, for example, byforming the shell using a flexible FDA approved low durometerencapsulant or a semi4igid plastic shell. The sensors 7 can be comprisedof two piezoelectric film foils composed of a polarized fluoropolymer,Polyvinylidene Fluoride (PVDF). The PVDF foils may be separated by apolyimide insulator 5. Electrical connections to each of the PVDF foilscan be accomplished by applying copper foil 4 to the outside surface ofeach foil. A two wire flexible circuit tail 3 may be soldered to thecenter of each copper foil 4. Each of these connections is secured andcovered using a strip of polyimide film insulator 99. The sandwichassembly can be held together using a flexible elastic adhesive 6 placedon the outer edges of the assembly. The force of a contraction distortsthe outer surface 8 which then applies strain to each of the pressuresensors. A small Voltage is produced in response to this strain due tothe piezoelectric effect. This signal can be processed and filtered by alow noise, JFET operational amplifier 29. The processed signal can bedigitized and further processed by microprocessor 34. Temperaturecompensation for these sensors may be provided using a thermistor 38which can be located, for example, 2 mm (or a similar distance as thesensors 7) from the outer surface 8. The thermistor 38 can also providetemperature compensation for the LED driver 31, the sensing cell 37, andthe accelerometer 32, as well as provide temperature measurement of theproximal environment.

FIGS. 8 and 9 illustrate another assembly method for the electroniccomponents supporting multiple embodiments of the present invention. Theassembly comprises a series of rigid substrates 9 to which thecomponents in chip scale form are attached to both the top and bottomsides of the substrate. This method produces a rigid flex assemblyoptimized for manufacturing. The substrates, for example, may becomprised of three layers of FR4 Printed circuit material having acombined thickness of approximately 0.35 mm. The substrates 9 have thenecessary conductive paths supporting the circuitry connections andattachment footprints for the integrated circuits and discretecomponents. The substrates can be interconnected using flexible,insulated fine pitch flat cable assemblies 15 which are embedded intothe substrates forming connections through the substrates middle layerto the top and bottom layers and components. This arrangement providesan assembly that can be populated with components using automatedassembly techniques when it is in flat form as illustrated in FIGS. 4and 5 but can be folded into a form for molding into a capsule shape orfor insertion into a pre-molded outer shell.

The top side of the rigid flex assembly is drawn in FIG. 8 . The imagecapture device 14, light source 13 and the light circuitry 12 arelocated on the topside of the first (left hand side) substrate 9. Thetopside of the second substrate may provide mounting pads for the sensorcell LEDs 16. The sensor array 17 resides on the top side of the thirdsubstrate. The sensor cell 37 can be mounted in the area between thesetwo substrates with terminal 21 forming the negative battery connectionand terminal 25 forming the positive battery connection. Terminal 25 maybe connected using a flex lead located between the batteries and thesubstrate 9. External battery terminals 22 and 23 may be formed byplating gold over nickel to the copper flex terminal pads. The locationof each of the required discrete components to support each major systemfunction will be determined by optimization of the printed wiring foreach substrate. Each substrate 9 may contain components in surface mounttechnology package form. Multiple ground traces 19 and positive batterytraces 18 can be used to reduce noise and power system impedance tosupport high current pulse loading. The connection between thetransceiver input/output can be accomplished using a shielded strip line20 between the top of the third substrate and the bottom of the fourthsubstrate where the chip antenna 36 can be mounted.

FIG. 9 illustrates a exemplary component layout for the bottom side ofthe assembly. The first substrate 9 (left side) may contain the NEToperational amplifiers 29 for processing the piezoelectric pressuresensors output and the thermistor 38 output. The sensor voltagereference and power switch circuitry 53 may also be located on thissUbstrate. Discrete components 28 supporting this circuitry may alsolocated OD this substrate surface. Flex tail connections 10, 11 for thepiezoelectric sensors 7 and the thermistor 38 may be provided on thissubstrate. The second, bottom side substrate may provide mounting padsfor a, three axis accelerometer 32, a sensor LEDs drive circuit 31 and apower switch 33. The third substrate 9 may contain a microprocessor 34and transceiver integrated circuit in a chip scale package with RFmatching components. The flex tail connection between substrates threeand four contains the strip line antenna trace 20, power, and groundconnections. The antenna 36 may attached to substrate four and theexternal, positive battery charge connection 23 may also originate fromthis substrate. A breakaway tab 35 can also attached to this substrate.This tab contains connections to the microprocessor's 34 interface. Thisinterface can be used for initial device and radio programming andin-process testing during production. After testing is complete the tabcan be removed from the substrate 9. The fifth substrate may provideroom for additional components which can include flash based memory fordata storage of sensed data and video. Use of this on-board Memory couldincrease the battery life by reducing the frequency of datatransmissions and will provide a backup record of all data collectedduring operation.

Folding of the rigid flex assembly can be accomplished, for example,using a mold with features for proper alignment of the substrates if theassembly is to be encapsulated using a 2 part room temperature mediumviscosity material. Alternatively, a fixture can be used that will alsohave alignment features and allow adhesive fixing of the substrates,sensing cell and battery in the final configuration for insertion into aplastic shell.

The locations of the batteries 39 and sensing cell 37 are clearlyillustrated in FIG. 10 . The image capture device 14 may require a shortfocal length lens. Once folded, the flex interconnect cables 15 betweenthe substrates 9 may fall alternately on the front side and back side ofthe assembly. The parallel connection between the batteries 39 negativeterminals can be accomplished using a polyimide film 40 with copperbattery terminals. The connection between the positive battery terminaland the top of the fifth substrate can be made using a flex tail 57. Thenegative battery connection can be carried through the system using, theflex tails 15 between the substrates.

Alignment features 53 in FIG. 11 may be added to the encapsulation moldto provide a method .for proper alignment of the capsule within thecharge/activation stand. These features may, for example, consist ofshall OW wells molded into the assembly designed to flute with a similargeometric post within the charge/activation stand capsule holdingassembly. These will ensure that external, battery terminals 22 and 23will mate properly with the correct polarity of the pointed terminalswithin the charge/activation stand if the capsule is not insertedproperly into the charge/activation stand then the capsule will sit toohigh in the stand to allow the pointed terminals to penetrate thecapsules shell.

An outer shell outline 56 is indicated in FIG. 10 . In this embodiment,thermistor 3S and piezoelectric sensors 7 are located close to the outershell 56.

In order to facilitate easy removal of the pill, a Dacron™ loop 27 maybe provided. The loop can be fixed to the end cap 63 of the firsthousing 1 and the plastic molded end the second housing 2. When the twomodules are screwed or snapped together the loop is internally securedto the end cap of second housing 2 or the capsule body using a smallplastic plate 26.

FIG. 11 illustrates an embodiment of the charge/activation andcalibration stand for the capsule. The charge/activation stand maycomprise a plastic shell containing a capsule fixing well 54 designed tohold capsule for activation calibration and charging. Two post-likefeatures 55 can be included and designed to insure proper alignment ofcapsule in the stand by mating with alignment wells 54. Two pointedbattery charging pins 55 may be provided and designed to pierce theself-healing silicon rubber caps on the capsules battery terminals 22and 23. The charge/activation and calibration stand may include a radiotransceiver designed to monitor and control the capsule duringoperation. The stand may include a USB to PC interface and a USB poweredbattery charging circuit. The USB interface can support data display onthe PC during operation, data downloading after removal of the pill, andprogramming of the pill prior to use. A hinged lid designed to hold thecapsule in position during charging and calibration can be used tosecure the pill during these operations, this feature is not shown inFIG. 11 . During operation collected data and pill status can alsomonitored using a patient worn device such as a wrist watch containing atransceiver and data display or a smart phone with a Bluetooth™application for data reception, communication with the pill, and displayof collected data. The images and video captured by the image capturedevice 14 are displayed on a monitoring device (e.g., cell phone, PCscreen, etc.). The user may optimize picture quality and participate inmonitoring their condition and communicating the information to healthcare providers.

An embodiment of the present invention would not include the chemicalsensing system and its associated detector. This embodiment would yielda device capable of measuring patient activity, heartbeats from motherand fetus, vaginal contractions and visual observations of dilation ofthe cervix. For this embodiment: the sample-on-demand functions that maybe initiated by the start of a contraction as sensed by theaccelerometer, heart rate, temperature and pressure sensors.

Another embodiment for this device would not include the chemicalsensing system and its associated detector. This embodiment wouldinclude a camera, an accelerometer, and an acoustic and piezo pressuredetector. This embodiment would yield a device capable of measuringpatient activity, heart rate of mother and fetus, frequency and durationof contractions, and provide photographic images of dilation of thecervix. For this embodiment the sample-on-demand functions that may beinitiated by the start of a contraction as sensed by the accelerometerand temperature sensors.

Embodiments of the present invention also include, without limitation,the following examples and combinations thereof.

Example 1. An implantable vaginal capsule for use in measurements ofsignals within the vaginal tract of a mammal, comprising, an electricpower source, a radio signal transmitter/receiver, and enablingcircuitry with said power source suitable for transmitting a radiosignal, and a source of said signal. The integrated radio communicationsassembly provides the device with the ability of accepting externalcommands via radio transmission, said external control of all datastorage, transmitting, collection methods and data sampling rates, saidexternal control to provide device status or change transmission modeson request. An internal operating program that provides the ability topre-program capsule responsiveness to events including sensor samplingrate adjustment and CMOS sensor and digital camera operation based onsensed data thresholds. All of the functional components of theimplantable vaginal capsule are encased in a non-digestible outer shellthat is configured to remain present in said vaginal canal while takingits measurements of said signals.

Example 2. The implantable vaginal capsule of Example 1, wherein thedevice is powered using coin cell type primary chemistry batteries anddevice activation is accomplished using an etched switch arrangementcontained within the end cap of the device.

Example 3. The implantable vaginal capsule of Example 1, wherein thesignal is digitized still frame or video sequence of images of theanatomical components of the vaginal canal or associated components ofthe internal environment including but not limited to fluids, blood andblood components, lesions, abnormal anatomical structures such ascarcinomas, and introduced radio-opaque substances employed forradiographic imaging, and not limited to additional imaging within thecapability of present and future digital imaging technology.

Example 4. The implantable vaginal capsule of Example 1, wherein thesignal is a physical measurement such as temperature, acoustic signals,pressure, and movement in three dimensional space.

Example 5. The implantable vaginal capsule of Example 1, wherein thesignal is a chemical measurement from a measurement sensor specific tothat chemical, and having output signals that may he stored, processed,anchor transmitted by the radio components of said vaginal capsule.

Example 6. The capsule of Example 1, wherein said electric power sourcecomprises one or more of a secondary chemistry coin shape battery havingbattery terminals sealed using self healing silicone rubber covers.

Example 7. The capsule of Example 1, wherein said transmitter emits aradio frequency (RE) signal, detectable outside of the shell of thecapsule, when enabled by said power source.

Example 8. The capsule of Example 1, wherein said power sourceconsumption is controlled by “smart software,” the software employingnumerous power modes to extend battery life.

Example 9. The capsule of Example 1, wherein software monitors thereceived data error rate for each data transmission and such informationis used by an adaptive RF power algorithm to adjust transmitter radiofrequency (RF) transmission power output thus saving battery power byreducing the number of retransmissions required.

Example 10. The capsule of Example 1, wherein internal non-volatilememory is used for the storage of sensed data and photographic images.

Example 11. The capsule of Example 1, wherein said receiver providesdirect control of radio frequency (RF) transmission modes includingburst type transmission to reduce power consumption.

Example 12. The capsule of Example 1, wherein said receiver allowsexternal commands to request transmission of capsule battery status,sensor and memory status, control of onboard CMOS camera mode andoperation, sensor sampling rate, and control of optical drive for thesensors.

Example 13. The capsule of Example 1, wherein said receiver/transmitteris capable of operation over 256 RF digital channels providing thecapability of monitoring multiple capsules operating in close proximitywithout interference.

Example 14. The capsule of Example 1, that uses a chemical sensingmethod to detect chemicals in the fluids of the vaginal tract for theentire time it is present in said vaginal tract.

Example 15. The capsule of Example 14, wherein said chemical sensingmechanism uses spectroscopic detection of analytes. More particularly,the present invention provides a device wherein the electromagneticradiation generator provides a substrate for chemical sensors, andwherein the spectroscopic properties of the chemical sensors aremodified upon contacting an analyte.

Example 16. The capsule of Example 14, which provides a method for theselective and simultaneous detection and continuous quantification ofmultiple analytes, and a method of making the device useful in thevaginal tract of an animal by incorporating a semi-permeable membrane toseparate undesirable substances from the continuously functioning sensorsites.

Example 17. The capsule of Example 14, having one or more chemicalsensors .for interacting selectively with a particular analyte in asample. In the absence of the analyte, the chemical sensor displayscertain baseline spectroscopic properties characteristic of the sensor.However, when the analyte is present in the sample, the spectroscopicproperties of the chemical sensor are modified. Detection andquantification of the analyte are based on a comparison of the modifiedproperties and the baseline properties.

Example 18. The capsule of Example 14, wherein a chemical sensorcomprises a reporter molecule whose spectroscopic properties aremodified in the presence of an analyte. The properties of the reportermolecule may he directly modified upon its interaction with the analyte.Alternatively, the reporter molecule may be attached to a templatematerial having a specific affinity for the analyte, in which case, theoptical properties of the reporter molecule are modified upon theinteraction of the template material with the analyte. Thus, by theterm. “spectroscopic properties of the chemical sensor” or “chemicalsensor's spectroscopic properties” is meant the spectroscopic propertiesof the reporter molecule and vice versa These properties may he opticalin nature when the emitted electromagnetic radiation is within thevisible spectrum, for example between about 400 nm to about 800 nm. Forexample, the chemical sensor could be a site selectively templated andtagged xerogel (SSTTX), a protein imprinted xerogel with integratedemission site (PIXIES), a surface bound antibody to a chemical, orprotein with an attached reporter. The reporter molecule may be one ormore photo luminescent reporter molecules within a molecularly templatedxerogel and the analyte affinity is afforded by the template siteswithin the xerogel. In another embodiment, the chemical sensor is aluminescent ruthenium based dye(tris(4,7-diphenyl-1,10-phenanthrolinetruthenium(11), ([Ru(dpp)3]2+),and the reporter molecule ([Ru(dpp)3]2+) provides an analyte-dependentphotoluminescence response directly.

Example 19. The capsule of Example 14, whereby types of analytes thatmay he detected include both liquid and gaseous materials. These includeCO2, O2, glucose, creatinine, prolactin, cystatin-A, Human chorionicgonadotropin (HCG), cytokines (IFN-gamma, IL-1, IL-6, IL-8, IL-10 andIL-12), other interleukins, peptides, carbohydrates, hormones such asestrogens, progesterones. Luteinizing Hormone (LH) or Lutropin,Follicle-Stimulating Hormone (FSH) and other fertility biomarkers,hemoglobin, proteins, peptides, pesticides, drugs, herbicides, anions,cations, antigens, oligonucleotides, fetal fibronectin,Alpha-fetoprotein (AFP, α-fetoprotein; also sometimes calledalpha-1-fetoprotein or alpha-fetoglobulin) and haptens. Proteins used asbiomarkers for diagnosis of cancer in the cervix, uterus or ovary may bedetected and used with or without images of the cervix far diagnosis,and be within the scope of the invention. Further, the present inventioncan indicate the pH and salinity of the fluids of the vaginal canal. Inanother embodiment of the invention, chemical sensors are available andcan be used in the present invention to detect the presence of organicmolecules such as polycyclic aromatic hydrocarbons, glucose, ketones,amines, amides, cholesterol, amino acids, and peptides. Further, thepresent invention can detect the presence of bacteria and viruses ofboth normal and pathogenic nature. There are many more substances whichcan be detected, and the foregoing list is not to be consideredexhaustive, but instead is merely representative.

Example 20. The capsule of Example 14, whereby the analyte-dependentspectroscopic signature from the chemical sensor may be detected. Oneconfiguration utilizes a detecting device in combination with areceiving and interpreting system. The receiving and interpreting systemhas a receiver to receive electromagnetic radiation transmitted oremitted by the chemical sensors) and convert the optical signal into anelectrical signal. An interpreter interprets the received electricalsignal. In an embodiment, an optical signal receiver is a complementarymetal oxide semiconductor (CMOS) based array with a filter preceding thereceiving surface on the CMOS array. The interpreter may include acontroller and a computer having software running thereon. In thisexample, the receiving surface is connected to the controller.

Example 21. The capsule of Example 14, wherein one or Moreelectromagnetic radiation filters may he placed between the substrateand the receiving surface. The filter selectively passes desiredwavelengths of the electromagnetic radiation moving from the detectingdevice toward the receiving surface and blocks undesired wavelengths.One example of a filter which can be used for this example is modelnumber Fire 419 manufactured by Roscolux of Stamford, Conn. Thisparticular filter passes electromagnetic radiation above approximately515 nm and strongly attenuates electromagnetic radiation belowapproximately 480 nm. Other gel type thin film filters or holographicnotch filters can also be used for this purpose. Other filters or filtercombinations are possible depending on the generator wavelength and theparticulars associated with a given sensor.

Example 22. The capsule of Example 14, wherein the sample to be analyzedis continuously exposed to the chemical sensor(s), and the receivercomponents are placed in the proper position to permit the receiving andinterpreting system to receive radiation from said chemical sensors.

Example 23. The capsule of Example 14, wherein the electromagneticinformation collected during operation is digitized to provide input toa digital memory during sensing, and sent to a receiving device overwireless communications at time intervals.

Example 24. The capsule of Example 14, using SSTTX-, or PIXIES-, orantibody capture based surface sensors. The analyte-dependentspectroscopic signal from these types of sensors is stable for many daysunder constant excitation or intermittent excitation at timed intervals.Thus, the chemical sensor platform is sufficiently stable to be used fordetection and quantification of analytes in the fluids of the vaginaltract over an extended time period.

Example 25. The capsule of Example 14, wherein the present exampleprovides a detecting device wherein the chemical sensor can be placed incontact with the electromagnetic radiation generator that excites theluminescent reporter molecules within the sensors, making the devicecompact and suitable for incorporation in the capsule of Example 4,Furthermore, the electromagnetic radiation used in the present inventionis not reflected, filtered, or transmitted over a long distance prior toreaching the chemical sensors, In addition, the detecting deviceaccording to the present example can be made relatively inexpensivelyand readily mass produced.

Example 26. The capsule of Example 25, wherein said xerogel-based sensorplatform continuously detects one or more analyte molecules in vaginalfluids in relation to concentration, and wherein analyte-dependentspectroscopic signal by the sensors occurs in strength proportional toanalyte concentration in vaginal tract fluids.

Example 27. The capsule of Example 25, wherein the vaginal fluid samplecontained may be removed and submitted to an external laboratory forchemical or genetic analysis in order to facilitate a medical diagnosisor a medical treatment decision.

Example 28. The capsule of Example 25, wherein said xerogel-based sensorplatform associates and dissociates reversibly to its analyte molecule,enabling continuous signal emulation in proportion to changingconcentration of said analyte molecules in vaginal fluids.

Example 29. The capsule of Example 25, wherein said molecular analysissubstance is any other composite or molecule which binds to itsconfigured specific analyte surface-enabling spectroscopic signalemulation in relation to concentration of said analytes or saidmolecules in vaginal fluids of a mammal.

Example 30. A capsule device for repeated detection of the concentrationof at least one analyte in a sample, comprising: an electromagneticradiation generating source haying at least one SSTTX-, PIXIES-, orantibody capture-based sensor formed directly on a substrate that is inturn in close proximity to the electromagnetic radiation generatingsource, such that the analyte-containing fluid can come into contactwith the sensor, wherein the spectroscopic properties of the chemicalsensor are modified in the presence of said analyte.

Example 31. The device of Example 30, wherein the electromagneticradiation generating source is a light emitting diode.

Example 32. The device of Example 30, further comprising a receiving andinterpreting system having an electromagnetic radiation receiver toreceive electromagnetic radiation emitted by the sensors, and configuredto interpret the received electromagnetic radiation.

Example 33. The device of Example 30, wherein the receiver includes afilter for selectively passing electromagnetic radiation.

Example 34. The device of Example 30, wherein the chemical sensingmechanism is fabricated as a pre-assembled apparatus containingxerogel-based sensing sites, wavelength filter, clear sealing windows,alignment features for radiation source and, detector.

Example 35. The capsule of Example 1, wherein the chemical sensing cellof Example 34 is filled with normal (0.9%) saline and covered with asemi-permeable membrane allowing communication between the membrane tobe sensed and the chemical sensing sites configured using anequilibration process.

Example 36. The capsule of Example 1, incorporating the chemical sensingcell of Example 34 wherein the wavelength tiller is deposited to thesurface of one of the optically clear seals, and the xerogel-basedsensing sites are printed directly onto this surface.

Example 37. The device of Example 30, wherein the receiver includes acomplementary metal oxide semiconductor (CMOS) based array chargecoupled device.

Example 38. The device of Example 30, wherein the receiver includes alens for focusing the electromagnetic radiation on the charge coupleddevice.

Example 39. The device of Example 30, wherein the receiver includes an.opaque shield above the lens for focusing the electromagnetic radiationon a complementary metal oxide semiconductor (CMOS) based array device.

Example 40. The device of Example 30, wherein the interpreter includes astorage component for storage for digitized data output from thecomplementary metal Oxide semiconductor (CMOS) array.

Example 41. The device of Example 30, further comprising a holdingsubstrate for holding the chemical sensors in optical alignment with theelectromagnetic radiation generating source, one or more filters, and areceiver.

Example 42. The device of Example 41, wherein the holding substrate is axerogel or other material (e.g., glass, plastic) that is not degraded inthe fluids of the vaginal tract.

Example 43. The device of Example 42, Wherein the holding material iscomprised of tetramethylorthosilane.

Example 44. The device of Example 30, wherein the chemical sensor(s)is(are) comprised of a reporter molecule and an analyte-responsivetemplate (e.g., SSTTX or PIXIES) having a specific affinity for theanalyte.

Example 45. The device of Example 30, wherein the reporter molecule isselected from the group consisting of fluorophore, phosphors,chromophore, and/or Raman scatterer.

Example 46. The capsule of Example 1, wherein the capsule's internalsignal measurement device can detect physical changes in temperature,pit vaginal fluid viscosity, three axis movement, acoustic signals,pressure changes associated with the contraction and relaxation ofvaginal walls and structures, and capture visual images of internalstructures as recorded with a digital still and video camera.

Example 47. The measurement system of Example 46, wherein the pressuremeasurement is detected using two piezoelectric polymer foil pressuresensors located near the surface of the capsules outer shell andcovering approximately 60% of the capsules circumference.

Example 48. The pressure measurement system of Example 46, whereintemperature compensation of the sensors and the temperature of thevaginal canal is measured using a temperature sensor located near thesurface of the capsules outer shell.

Example 49. The capsule of Example 1, wherein acoustic signals aredetected using the piezo pressure sensors or a small MEMS based digitalmicrophone. Microphones of this type are currently available in formfactors that occupy less that 0.7 mm of space making them ideal for thisapplication. Said acoustic signals include but are not limited to heartrate, breathing cycles and bowel sounds.

Example 50, The capsule of Example 46, wherein the measurement andrecord of patient movement and physical activity is determined using athree axis accelerometer.

Example 51. The capsule of Example 1, wherein the capsule contains aremote actuatable storage reservoir which comprises a radio signalreceiver configured to receive a signal from a remote transmitterpositioned exterior of said outer shell of said capsule.

Example 52. The transmitter of Example 51, contained in a form factorthat can be worn by the patient as a wrist watch or incorporated as aBluetooth™ application for a smart phone.

Example 53. The capsule of Example 1, wherein said outer shell comprisesa low durometer plastic encapsulant or thin polycarbonate shell.

Example 54. The capsule of Example 1, that will provide chemical sensingon a continuous basis in any fluid containing environment of animals.

Example 55. The capsule of Example 1 that will provide sensing in anyenvironment where external temperature is −10 to 75 degrees centigrade.

Example 56. The capsule of Example 1, wherein said enabling circuitrycomprises a rechargeable battery and self sealing connections to anexternal battery charging system to act as a switch.

Example 57. A vaginal capsule for insertion into the vaginal canalcomprising, a non-digestible outer shell; an electric, power source; aradio signal transmitter/receiver with enabling circuitry; said powersource suitable for transmitting a signal; the capsule capable ofdetecting changes in vaginal pH, pressure, temperature, motion, acousticsignals, and visual conditions of structures such as the cervicalopening to the uterus of a mammal.

Example 58. The device of Example 57, wherein a quantified DC voltagesignal is digitized to provide input to a computer.

Example 59. The device of Example 57, wherein a time multiplexed outputof the multiple sensors is converted to an intermediate frequencysignal, quantified as a DC voltage signal and digitized to provide inputto a computer.

Example 60. The device of Example 57, wherein said transmitted signalsare received exterior of the animal body digitized and provided to acomputer.

Example 61. The device of Example 57, wherein said digitized informationhas data regarding the length of time of said capsule in said canal

Example 62. The process of Example 56, wherein said computer isprogrammed to scan and compute variations from pre-programmed factors.

Example 63. The process of Example 57, wherein said capsulereceiver/transmitter can accept external commands during operation tochange sensed parameter sampling rates, activate the digital camera, orreport status of the capsule's systems.

Example 64. A process for the continuous collection of sensing data inthe vaginal canal of an animal comprising: providing an insertablecapsule containing a microprocessor suitable for determiningmeasurements and storing data; receiving a transmitted signal exteriorof the body of said at digitizing said signal received by saidmicroprocessor; storing said digitized signal in computer recoverable,time sequence memory.

Example 65. An insertable capsule for continuous collection of sensingdata in the vaginal canal of an animal comprising, a non-digestibleouter shell; an electric power source; a radio signal transmitter inenabling circuitry with said power source suitable for transmitting aradio signal the location from which it emanates in said canal.

Example 66. The capsule of Example 64, comprising a measurement deviceto measure sensing signals from vaginal fluids, and said output isconverted to time multiplexed output.

Example 67. The vaginal capsule of Example 1, with an electronic datacapture and processing configuration incorporating sensors, used formonitoring of a pregnancy in a female mammal.

Example 68. The vaginal capsule of Example 1, with an electronic datacapture and processing configuration incorporating sensors for glucose,used for monitoring of diabetes in a female mammal.

Example 69. The vaginal capsule of Example 1, with an electronic datacapture and processing configuration incorporating sensors, used formonitoring of fertility, for use in natural contraception, or naturalcontraception.

Example 70. The vaginal capsule of Example 1, with an electronic datacapture and processing configuration incorporating sensors, used for amonitoring, of and adjustment of hormonal balance in pre-menopausalfemale mammals.

Example 71. The vaginal capsule of Example 1, with an electronic datacapture and processing configuration incorporating sensors, used formonitoring of and adjustment of hormonal balance in post-menopausalfemale mammals,

Example 72. The vaginal capsule of Example 1, with an electronic datacapture and processing configuration incorporating sensors, used formonitoring of vaginal bleeding and associated conditions in femalemammals.

Example 73. The vaginal capsule of Example 1, with an electronic datacapture and processing configuration incorporating sensors, used formonitoring of organic sexual dysfunction of the female genital tract ofa mammal.

Example 74. The vaginal capsule of Example 1, with an electronic datacapture and processing configuration incorporating sensors, used formonitoring of vaginal and uterine cramping in female mammals.

Example 75. The vaginal capsule of Example 1, with an electronic datacapture and processing configuration incorporating sensors, used formonitoring of subject heart rate and breathing cycles.

Example 76. The vaginal capsule of Example 1, with an electronic datacapture and processing configuration incorporating sensors, used formonitoring of vaginal inflammation or infections of the female genitaltract of a mammal.

Example 77. The vaginal capsule of Example 1, with functional componentsexcluding the chemical measurement sensors, used for measurement ofphysical processes inside the female genital tract of a mammal andincorporating video or digital image capture.

Example 78. The capsule of Example 1, with functional componentsincluding or excluding the chemical measurement sensors, used formeasurement of physical processes inside the rectal orifice of a mammaland incorporating video or digital image capture.

Example 79. The capsule of Example , with functional componentsincluding or excluding the chemical measurement sensors, used formeasurement of physical processes inside the oral orifice of a mammaland incorporating video or digital image capture.

Example 80. The capsule of Example 1, wherein the electronic componentsused within the capsule are contained on a series of rigid substratesinterconnected with fine pitch flat flexible wiring.

Example 81. The capsule of Example 80, wherein the rigid flex assemblyis designed to be folded providing proper alignment of all componentsand insertion into an outer protective shell.

Example 82. The capsule of Example 80, wherein the folded assembly isinserted into a mold and the outer shell is encapsulated using an FDAapproved 2-part medium viscosity compound.

Example 83. The capsule of Example 80, wherein a multi-purpose capsuleactivation stand that communicates with a PC via a USB port is usedprior to capsule use to charge the capsules internal battery, calibratethe capsules sensors, and test all inter-capsule functions, and functionas a receiver for the capsule during normal operation.

Example 84. The multi-purpose capsule activation stand of Example 83,wherein the multi-purpose capsule activation stand is used to programthe capsule. Programmed functions will include setting sensed datathresholds for event triggering: such as activating on board cameras,setting the transmit and receive: RE channels for the capsulestransceiver, setting sensor sample rates and sample rate changes due tosensed data thresholds being met.

Example 85. The capsule of Example 1, wherein external communicationwith the capsule for both receiving capsule data and controlling thecapsules cameras, sensor sampling rate and power mode are provided usinga transceiver having a USB thumb drive form factor connected to a PC.

Example 86. The capsule of Example 1, wherein external communicationwith the capsule for both receiving capsule data and controlling thecapsules cameras, sensor sampling rate and power mode are provided usinga patient worn small battery powered transceiver and data collectiondevice providing maximum patient mobility. Data collected may bedownloaded to a PC upon completion of the test.

Example 87. The capsule of Example 1, wherein external communicationwith the capsule for both receiving capsule data and controlling thecapsules cameras, sensor sampling rate and power mode are provided by aapplication running on a “Smart Phone” or other hand held personalcommunication device.

Example 88. The capsule of Example 1, wherein the said enablingcircuitry comprises a polymeric seal about conductive terminals tocharge and/or activate the batters prior to use and provide removal,cleaning, recharge and reinsertion patient cycles without compromisingdevice integrity.

Example 89. The capsule of Example 1, wherein the components of module 2illustrated in FIG. 3 can be replaced with a new module by a simpleprocedure, creating a disposable laboratory component to the vaginalcapsule assembly. A further embodiment of the capsule in Example 1 doesnot include the chemical sensing system and detector.

Example 90. The capsule in Example 89, that provides a sample-on-demandfunction based upon a pre-defined sensing threshold for the imaging,pressure, accelerometer, acoustic, and temperature sensors.

Example 91. A further embodiment of the capsule in Example 1 that doesnot include the chemical sensing system or the piezo pressure sensor.

Example 92. The capsule in Example 91 that provides a sample on demandfunction based upon a pre-defined sensing threshold for theaccelerometer and temperature sensors.

Although the present invention has been described with respect to one ormore particular embodiments, it will be understood that otherembodiments of the present invention may be made without departing fromthe spirit and scope of the present invention. Hence, the presentinvention is deemed limited only by the appended claims and thereasonable interpretation thereof.

1. A computer-implemented system for assessing female fertility, thesystem comprising: a. an intravaginal capsule configured for retrieval,wherein the intravaginal capsule comprises: a housing; a camera mountedto the housing and configured to receive computer-implemented signals toobtain at least one cervical image; one or more first sensors mounted tothe housing and configured to measure one or more intravaginalparameters relating to the female fertility; one or more second sensorsmounted to the housing and configured for continuous measurement of atleast one biochemical parameter; at least one computer processor mountedto the housing, wherein the computer processor provides fertilityinformation based on one or more of the at least one biochemicalparameter and the one or more intravaginal parameters; and at least onememory device; and b. an electronic connection configured to transmitthe at least one cervical image to at least one computing device,wherein the computing device is selected from the group consisting of awearable device, a wristwatch and a smartphone, wherein at least one ofsaid one or more second sensors is configured to contact vaginal fluidwith a sensor substance adapted to reversibly interact with an analyteof interest, the sensor substance configured to emit electromagneticenergy when the analyte of interest is in contact with the sensorsubstance and electromagnetic excitation energy is received by thesensor substance.
 2. The system of claim 1, wherein the housing furthercomprises one or more of an image-capture device, and at least oneparametric sensor configured to measure the one or more intravaginalparameters, and wherein the one or more intravaginal parameters areselected from the group consisting of vaginal temperature,labor-contraction timing and intensity, vaginal pressure and vaginalmotion.
 3. The system of claim 2, wherein the one or more cervicalimages are obtained by the image-capture device, and wherein the imagecapture device is configured for one or more of high-resolution imaging,video capture, and intravaginal illumination.
 4. (canceled)
 5. Thesystem of claim 2, wherein a 3-axis accelerometer is used to detect thevaginal motion, and wherein sexual arousal is indicated when the 3-axisaccelerometer detects vaginal motion that is increased compared to areference standard.
 6. The system of claim 2, wherein a detectedreference standard deviation in one or more of the vaginal temperature,labor-contraction timing and intensity, vaginal pressure, and vaginalmotion triggers an alert signal.
 7. (canceled)
 8. The system of claim 6,wherein the alert signal is a Flibanserin monitoring signal.
 9. Thesystem of claim 1, wherein the system is configured for initiating useof and controlling the retrievable capsule and the electronicconnection.
 10. The system of claim 9, wherein the initiation andcontrolling are selected from the group of consisting of positioning theretrievable capsule intravaginally, receiving the intravaginalparameters on the wearable device, wristwatch or smartphone, imagecapturing, transmission of the cervical images, and intravaginalillumination.
 11. (canceled)
 12. (canceled)
 13. An intra-bodycommunication and data processing system for monitoring fertility in apatient in need thereof, the system comprising: a capsule configured tobe reversibly insertable into the patient's body; a device spaced apartfrom the capsule, wherein the capsule and the device are configured forcommunication including transmitting one or more signals between thecapsule and the device; and a receiver for detecting the one or moresignals to monitor the fertility, wherein the one or more signals carryphysiological information selected from the group consisting of vaginalcontractions, vaginal temperature, vaginal pH, vaginal fluid glucose,vaginal fluid hemoglobin, labor-contraction timing and intensity,vaginal pressure, vaginal motion, ovulation parameters, hormonalimbalances, cervical dilation, vaginal contraction, an illuminationsignal, and one or more cervical images, wherein the one or more signalsare configured for comparison with a reference signal from the patientto monitor fertility in the patient.
 14. The system of claim 13 furthercomprising: a at least one computer processor, wherein the computerprocessor provides fertility information to the patient based on the oneor more signals; and b. at least one memory device.
 15. The system ofclaim 13, wherein the capsule further comprises one or more of animage-capture device, and at least one parametric sensor configured tomeasure the one or more signals, and wherein the image capture device isconfigured for one or more of high-resolution imaging, video capture,and intravaginal illumination.
 16. (canceled)
 17. (canceled) 18.(canceled)
 19. A method of in vivo monitoring of a pregnant individual,comprising the steps of: providing a retrievable device comprising ahousing; inserting the retrievable device in the vaginal tract of theindividual; activating a light source mounted to the housing toilluminate at least a portion of a cervical opening of the individual;operating an image capture device mounted to the housing to capture animage of at least a portion of the cervical opening of the individual;operating one or more first sensors mounted to the housing to measureone or more intravaginal parameters relating to the female fertility;operating one or more second sensors mounted to the housing to measureat least one biochemical parameter; controlling the operation of theimage capture device with a trigger signal generated based on the atleast one measurement corresponding to a labor contraction;automatically generating fertility information based on one or more ofthe at least one biochemical parameter and the one or more intravaginalparameters; and transmitting the image and the fertility information toa wearable device, wristwatch, or smart phone.
 20. The method of claim15 wherein the biochemical parameter is an analyte in a vaginal fluid ofthe individual, the operating of said one or more second sensorsmeasuring concentration of said analyte concentration continuously.